Urocidin™ U.S. Regulatory Pathway
A meeting with the U.S. Food and Drug Administration to discuss the potential for accelerated approval of
that had been scheduled for
December 18, 2013
has now been postponed to allow the Company additional time to gather information required by the regulator. A new meeting date will be set once this information has been put together.
Given the very low level of trading on the Australian Securities Exchange (ASX), the small number of CDIs remaining, and the significant liquidity for Bioniche shares on the Toronto Stock Exchange (TSX), it intends to delist from the official list of the ASX, subject to ASX approval. As a result of the delisting, the Company expects to realize a savings in administrative and compliance obligations. Following the delisting, Bioniche Common Shares will continue to trade on the TSX.
All holders of CDIs will be offered several alternatives, including selling or transferring their holdings to the TSX, where there is a more liquid market. CDI holders will be sent an information package in due course which explains in detail the options available to them. It is important that CDI holders take time to consider this information package carefully.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and One Health. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.
Bioniche Animal Health develops, manufactures and markets veterinary biopharmaceutical products worldwide. In
, it has development, manufacturing and marketing facilities in
Belleville, Ontario, Canada
, U.S.A. and
, U.S.A. In
, business is conducted from Armidale,
New South Wales
, where research, development and manufacturing facilities are located. The Company engaged Evercore in May, 2013 to lead the divestment of its Animal Health business unit. At such time as a definitive agreement is reached, the proposed sale transaction will be presented to Company shareholders for a vote.
For more information, please visit
Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
SOURCE Bioniche Life Sciences Inc.